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A Phase 3 Randomized, Open-label, Active-comparator Controlled Clinical Study of Pembrolizumab Versus Platinum Doublet Chemotherapy in Participants With Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma in the First-line Setting (KEYNOTE-C93/GOG-3064/ENGOT-en15)
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Eligible participants will be randomly allocated to either the Experimental Arm or Active Comparator Arm. In the Experimental Arm, participants will receive pembrolizumab (400mg) via intravenous infusion (IV) on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years). In the Active Comparator Arm, participants will receive a combination of paclitaxel (175mg/m^2) on Day 1 of each 3-week cycle and carboplatin (AUC 5 or 6) on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months). Participants who experience a severe hypersensitivity reaction to paclitaxel or an adverse event (AE) requiring discontinuation of paclitaxel may receive docetaxel (75mg/m^2) in place of paclitaxel on Day 1 Q3W after Sponsor consultation. Participants who experience a severe hypersensitivity reaction to carboplatin or an AE requiring discontinuation of carboplatin may receive cisplatin (75mg/m^2) in place of carboplatin on Day 1 Q3W after Sponsor consultation.